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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K252295
Device Name Ryurei
Applicant
Terumo Corporation
44-1, 2-Chome, Hatagaya
Shibuya-Ku
Tokyo,  JP 151-0072
Applicant Contact Kirsten Steinmann
Correspondent
Terumo Medical Corporation
265 Davidson Ave.
Suite 320
Somerset,  NJ  08873
Correspondent Contact Kirsten Steinmann
Regulation Number870.5100
Classification Product Code
LOX  
Date Received07/23/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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